Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Bd — Predicate Candidate Screening

15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

72 daysmedian FDA review time

144 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K253445	BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (91012	Bd	2026-02-20	141	0
K240257	Denali™ Vena Cava Filter System – Femoral and Jugular/Subcla	Bd	2024-02-29	29	0
K232434	BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waive	Bd	2023-12-05	116	0
K223016	BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waiv	Bd	2023-01-27	120	0
K221504	BD Surgiphor™ Antimicrobial Irrigation System	Bd	2022-10-14	144	0
K180438	BD Veritor System for Rapid Detection of Flu A + B CLIA waiv	Bd	2018-03-20	28	1
K024240	BD VACUTAINER PLUS PLASTIC URINE C&S PRESERVAYIVE TUBES AND	Bd	2003-03-26	93	3
K023752	BD INTEGRA SYRINGE	Bd	2003-02-07	91	2
K021475	BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET	Bd	2002-07-19	72	1
K020523	BD BIFURCATED NEEDLE, MODELS 301754, 301755, 301756, 301757	Bd	2002-03-20	29	0
K011967	BD PRE-FILLED HEPARIN LOCK FLUSH IN 0.9% SODIUM CHLORIDE INJ	Bd	2002-01-23	212	0
K012584	MODIFICATION TO: BD DURASAFE PLUS EPIDURAL LOCK CSE NEEDLE S	Bd	2001-09-06	27	0
K011982	0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRI	Bd	2001-07-17	21	0
K011858	INTERLINK THREADED LOCK CANNULA	Bd	2001-06-19	5	0
K011103	BD SPRING BASED SYRINGE	Bd	2001-06-13	63	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda